Kornimate/medical-research-clean huggingface dataset:
treatment of knee pain with topical diclofenac cream 8% or diclofenac gel 1%

Conditions: Knee Pain Chronic; Knee Injuries

Summary: non-steroidal anti-inflammatory medication (nsaid) therapy is a mainstay treatment for joint pain and painful musculoskeletal disorders. though this form of systemic therapy is highly effective, it causes substantial side effects including gastritis and gastric ulcer disease, renal impairment, hypertension, and thrombotic events. these types of oral medications are utilized by millions of americans on a fairly regular basis in both over-the-counter preparations and prescription compounds. in recent years, topical preparations of nsaids have been used for localized pain as an alternate to oral administration with reported good analgesic efficacy. for example, they are often used for knee pain. there is little systemic absorption of nsaids with topical administration, and consequently less likelihood of systemic side effects. though much less studied than oral nsaids, topical nsaid preparations are currently prescribed for a variety of arthritic and musculoskeletal types of pain. the best-studied commercially available products are diclofenac 1% compounds. higher concentrations presumably provide higher tissue concentration leading to better and longer pain relief, along with a more prominent anti-inflammatory effect. the investigators will therefore compare the efficacy of available topical diclofenac 1% gel to that of diclofenac 8% cream. specifically, the investigators propose to test the hypothesis that efficacy of topical diclofenac 8% exceeds that of diclofenac 1%, without any increase in systemic toxicity. one hundred six patients presenting to the cleveland clinic pain management department for the treatment of knee pain will be randomly assigned to topical diclofenac cream 8% or diclofenac gel 1%, with the designated medication applied the symptomatic area of the knee over 6 weeks. investigators will be blinded to treatment, and will evaluate pain relief and functional/disability status.


Eligibility criteria:
inclusion criteria: * acute and chronic knee pain, along with postoperative knee pain lasting at least two months. exclusion criteria: * patients will be excluded if deemed inappropriate for application of topical medication therapy by the treating physician. this will include adult patients with diffuse (non-localized) pain disorders and those likely to need knee surgery during the treatment period. * patients with knee infection, open knee wounds, or acute knee skin lesions will be excluded. * patients with diclofenac or wheat or gluten allergies will also be excluded.
bowel preparation in minimally invasive gynecologic surgery

Conditions: Gynecologic Disease

Summary: this is a prospective randomized study of patients who are scheduled to undergo minimally invasive robotic gynecologic surgery. patients will be randomized to require either pre-surgical bowel preparation vs. no bowel preparation. the effect of bowel preparation on intraoperative visualization, bowel handling, intestinal load and ease of surgery will be assessed. patient comfort and satisfaction will be assessed.

bowel preparation prior to gynecologic surgery is a common practice based more on assumptions than evidence. expert opinion rules over evidence regarding its utility and necessity. the objective of this study is to determine if there is an association between the use of bowel preparation in minimally invasive gynecologic surgery and the ease of the surgery. this is a randomized controlled trial of adult patients of dr. muhammad aslam who are scheduled to undergo minimally invasive robotic gynecologic surgery at henry ford st. john hospital and henry ford macomb-oakland hospital-warren campus. patients will be randomly assigned to receive or not receive instructions to perform bowel preparation one day prior to surgery using an over-the-counter fleet® saline enema. data to be collected include demographics, body mass index (bmi), parity, and surgical history. data collection from patients will be performed on postoperative day one prior to discharge from the hospital. data collection will include patient satisfaction with having to use or not using bowel preparation for surgery and pain control. dr. aslam will complete a survey following each surgery about intraoperative visualization, bowel handling, intestinal load, and the overall ease of surgery. according to the power analysis, at least 75 subjects will be needed in each group, for a total of 150. to account for attrition, the sample size will be inflated by 10% plus an additional one subject, to maintain an even number of subjects (166 subjects). three hundred patients may need to be initially screened to obtain 166. univariable analysis of factors associated with the bowel preparation group will be assessed using student's t-test and chi-squared analysis. multivariable analysis of acceptable bowel preparation will be done using logistic regression.

Eligibility criteria:
inclusion criteria: * scheduled to undergo minimally invasive robotic gynecologic surgery; * age 18 years and above * willing to perform an enema if randomized to the enema group * able to read and understand english * willing to sign an informed consent form exclusion criteria: * scheduled for open surgery * younger than 18 years of age * unwilling to perform an enema if randomized to the enema group * unable to read and understand english * unwilling to sign an informed consent form

Keywords: gynecologic surgery bowel preparation patient satisfaction ease of surgery
genetic risk stratification of pediatric skin lesions

Conditions: Skin Lesion; Nevus

Summary: a study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether dermtech pigmented lesion assay (pla) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.

patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. prior to surgical biopsy, a dermtech pla noninvasive adhesive will be performed on the lesion. the results of dermtech pla genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. incidents of adverse events will also be collected.

Eligibility criteria:
inclusion criteria: * 20 years of age or younger. * subjects or parents willing and able to give informed consent, and assent as appropriate * patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months exclusion criteria: * lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed * bleeding or ulcerated lesions * previously biopsied, scarred, or known melanoma lesions * presence of active psoriasis/eczema/other skin condition in area to be biopsied
lesion-to-lesion comparison of 68ga-ha-dotatate, 18f-dopa, and 18f-fdg pet/ct in the evaluation of metastatic neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: this study is a single centre non-randomized non-blinded phase ii prospective cohort study including 50 participants. the objective of this study is to directly compare 68ga-ha-dotatate, 18f-dopa, and 18f-fdg activity in patients with metastatic neuroendocrine tumors (nets) on a lesion-by-lesion basis. the investigators will determine the prevalence of concordant versus discordant disease. secondary objectives include assessing the standardized uptake value (suv) and determining if there is any correlation between discordance and disease progression.


Eligibility criteria:
inclusion criteria: * history of biopsy proven neuroendocrine tumor including (but not limited to): gastrointestinal net, pancreatic net, pulmonary net, net unknown primary, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma * at least two abnormal 68ga-ha-dotatate positive lesions suspected to represent neuroendocrine tumor (at least tow lesions with suvmax \> suv meanliver). * age greater or equal to 40 * ability to provide written informed consent prior to participation in the study exclusion criteria: * weight \> 225 kg (weight limitation of pet/ct scanner) * inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging * any medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation * previous allergic reaction to 18f-dopa * lack of intravenous access * pregnant * breastfeeding * less than 40 years old
biological assessment of clinical nutrition and its application

Conditions: Malnutrition

Summary: 1. clinical nutritional support therapy is an important progress of modern medicine. 2. conventional methods of clinical nutrition assessment (anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status. 3. it has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. this preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells. 4. in the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.there were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients. 5. based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, maintain this amount of nutrition given until the end of treatment. the investigators call this amount of nutrition the "upper limit nutrition support therapy". 6. the patients applying for"upper limit nutrition support therapy" and "formula nutrition support therapy" separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.


Eligibility criteria:
inclusion criteria: 1. patients with gastric cancer or colorectal cancer which confirmed by preoperative pathology will be included. 2. patients who are diagnosed as malnutrition according history, physical examination and nutrition risk screening 2002 will be included. 3. patients who have digestive tract fistula because of operation complication will be included. 4. patients who need fast track recovery after colorectal cancer operation will be included. exclusion criteria: 1. patients who are diagnosed as late stage (stage iv) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded. 2. postoperative gastric cancer or colorectal cancer patients who is unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded. 3. patients with severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded. 4. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.

Keywords: nutritional assessment oral epithelial cell apoptosis
clinical trial in females for female pattern hair loss

Conditions: Androgenetic Alopecia

Summary: this is a six month clinical trial to evaluate the effectiveness and safety in women with female pattern hair loss (fphl), comparing a 5% minoxidil topical foam (mtf) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.

this is a phase 3, two-arm, randomized, double-blind, vehicle-controlled, multi-center, 24-week, parallel design trial to evaluate the efficacy and safety in women with female pattern hair loss (fphl), comparing the 5% mtf formulation versus the foam vehicle formulation. this clinical trial is designed to compare the risk/benefit profile of the new 5% mtf formulation applied once a day (od) versus the foam vehicle formulation applied once a day (od), using objective efficacy measures and safety assessments. study centers will screen a sufficient number of participants so that a minimum of 300 female participants with fphl will be enrolled, to ensure 260 complete. there will be at least 16 participants enrolled per center at multiple centers located across the us and globally. approximately 300 participants will be randomly assigned in a 1:1 ratio to use either 5% mtf od or foam vehicle od, for 24 weeks for efficacy and safety evaluations. participants meeting the inclusion criteria will be randomly assigned in the order of their enrollment at each site. the signing of the informed consent and assignment of a participant number to a subject shall constitute enrollment. during the trial following enrollment at baseline, participants will return to the study site at weeks 1, 6, 12, 18 and 24 for safety assessments, adverse events monitoring, and compliance assessments. at the week 12 and 24 visits, efficacy assessments will also be conducted, using target area hair counts (tahc), measured by macrophotography.

Eligibility criteria:
inclusion criteria: * females, age 18 or older in general good health * exhibits female pattern hair loss * signs and dates an informed consent document * agrees to use an adequate method of birth control; if of childbearing potential * shows a negative urine pregnancy test at screening visit * is willing to maintain the same hair style, hair color, and hair regimen throughout the study * is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures exclusion criteria: * hypersensitivity to the (study product), or any ingredients of the (study product) * known allergy to hair dye, or hair dye components * clinically relevant history of hypotension * untreated or uncontrolled hypertension * pregnant, planning a pregnancy or nursing a child * history of hair transplants * currently use hair weaves or non-breathable wigs * dermatologic disorders of the scalp that require chronic use of medication for control * other types or history of hair loss * enrolled in any other investigational medication (drug) study currently, or within the last 6 months

Keywords: female pattern baldness
the efficacy of mesenchymal stem cells for stimulate the union in treatment of non-united tibial and femoral fractures in shahid kamyab hospital

Conditions: Nonunion Fracture

Summary: because the rate of non union of long bone in lower extremities specially in tibia in this two last decade due to malnutrition and smoking and other risk factors was increased, so many patient in our country suffer from non union on the other hand it seems that the use of the mesenchymal stem cells can irritate the union rate. therefore the investigators decide to inject the mesenchymal stem cell derived from iliac bone marrow after centrifuge with ficoll procedure to non union site in patient that are resistant to other treatment. then the investigators will follow the patient with monthly radiography and evaluate the callus volume and clinical union and any side effect of this treatment.clinical union consider to relief pain in non union site and be stable in examination.


Eligibility criteria:
inclusion criteria: * every patient with non union in the site of long bone fracture * age more than 18 and under 60 years old * fracture having no radiological callus after 6 months and absence of any hypertrophic bone reaction. * no infection in site of surgery * be able and willing to participate in the study * written informed consent exclusion criteria: * evidence of malignancy * pregnancy or breastfeeding * patient positive by serology or pcr for hiv, hepatitis b or c infection the patient with accompanied fracture such as hip fracture that could not weight bearing

Keywords: nonunion mesenchymal stem cell long bone
enhancing recovery in non-traumatic spinal cord injury

Conditions: Spinal Cord Compression; Spinal Cord Injuries; Cervical Spondylosis; Myelopathy Cervical

Summary: the investigators have spent the last decade uncovering unique metabolic and functional abnormalities in the brains of patients with spinal cord compression. degenerative spinal cord compression represents a unique model of reversible spinal cord injury. in the investigator's previous work, they have demonstrated that cortical reorganization and recruitment is associated with metabolic changes in the brains of patients recovering from spinal cord compression and is correlated with recovery and improved neurological scores. the goal of this study is to combine a rigorous platform of clinical care that includes preoperative evaluation, surgery, and rehabilitation, with state of the art imaging techniques to demonstrate how rehabilitative therapy can increase brain plasticity and recovery of neurological function in patients with spinal cord injury. neurological function will be carefully evaluated in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and will be correlated with the results of advanced imaging.


Eligibility criteria:
inclusion criteria: * right-handed * have a history of progressive neurological deficits \<24 months * eligible for mri scanning exclusion criteria: * having any other neurological disorder or systemic disease that can impair neurological function * not fluent in reading and speaking english * being claustrophobic * unable to follow simple task instructions and maintain standardized movements * being unable to return for all follow-up imaging and rehabilitation sessions
a study of a new chemotherapy agent in combination with cisplatin to treat small cell lung cancer

Conditions: Carcinoma, Small Cell

Summary: the purpose of the study is to determine whether the study drug zk 219477 (also known as sh y03757a) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * small-cell lung cancer * stage of extensive disease * adequate function of major organs and systems * use of highly effective birth control methods in females of child-bearing potential exclusion criteria: * prior chemotherapy for small-cell lung cancer * prior surgical resection or radiotherapy for sclc within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases * superior vena cava syndrome or obstruction of any vital structure * untreated malignant hypercalcemia; extensive disease amenable to radiation therapy; symptomatic brain metastases requiring whole-brain irradiation * known allergy or hypersensitivity to platinum-containing drugs * pregnancy or breast-feeding * use of any investigational drug within 4 weeks before start of the study

Keywords: small cell lung cancer
us 10 ml biologic lung volume reduction (blvr) phase 1 emphysema study

Conditions: Pulmonary Emphysema

Summary: the purpose of this study is to evaluate the safety of the biologic lung volume reduction system (blvr) for patients with advanced emphysema.

emphysema is a progressive, debilitating disease that affects nearly 3 million people in the united states or roughly one percent of the us population. the disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. the most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the united states. currently there are 46 million smokers in the us. due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the united states for years to come. aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. the biologic lung volume reduction (blvr) system, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. the resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. this study will evaluate the safety of the blvr system in patients with advanced emphysema.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of advanced heterogeneous emphysema * age \>/= 40 * clinically significant dyspnea * failure of standard medical therapy to relieve symptoms * pulmonary function tests with protocol-specified ranges exclusion criteria: * alpha-1 protease inhibitor deficiency * tobacco use within 16 weeks of initial clinic visit * body mass index \ 35 kg/m@ * clinically significant asthma, chronic bronchitis or bronchiectasis * allergy or sensitivity to tetracycline * prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

Keywords: lung volume reduction bronchoscopy emphysema copd nett lung disease cold blvr
ebus-tbna vs flex 19g ebus-tbna

Conditions: Lymphadenopathy; Lung Cancer; Sarcoidosis; Lymphoma

Summary: this is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (ebus-tbna). patients undergoing ebus-tbna for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either ebus-tbna or flex 19g ebus-tbna. the procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. specimens will be placed in saline and formalin and forwarded to the pathology laboratory. the specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.the pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.


Eligibility criteria:
inclusion criteria: 1. scheduled for ebus-tbna as part of clinical care 2. lymph nodes larger than 10mm in diameter 3. age \> 18 years 4. written informed consent exclusion criteria: 1. contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia) 2. inability to obtain informed consent